2023 ACIP Updates for Immunizations in Adults and Children: What ...
CDC Advisors Back RSV Vaccine For Older Adults, With Caveats
The CDC's advisors on Wednesday recommended the newly approved respiratory syncytial virus (RSV) vaccines for older adults, but opted not to give their strongest endorsement.
In a series of two votes, the Advisory Committee on Immunization Practices (ACIP) said that adults 60 and older may receive one dose of the recently approved RSV prefusion F protein-based vaccines after discussions with their health provider.
Originally, the CDC had asked ACIP to vote on broadly recommending the vaccines to people 65 and older, but that plan got tweaked during discussions earlier in the day.
"I'm torn about making a universal recommendation for 65 years of age and older," said Pablo Sanchez, MD, of Nationwide Children's Hospital in Columbus, Ohio, who recommended including the shared decision-making language.
Ultimately, the committee voted on recommendations that included that language both for people 60 to 64 years (13-0 vote in favor, with one abstention) and for people 65 and up (9-5 vote in favor).
Other ACIP members, however, wanted the broad recommendation for all of these older adults.
"I think we should remove the clinical decision-making altogether, and just bring the age down to 60," said Lynn Bahta, RN, MPH, of the Minnesota Department of Health in Saint Paul, suggesting the narrow recommendation might further disparities.
Historically, when the flu vaccine recommendation went from a risk-based recommendation to being recommended for everyone, coverage increased from 38% to 50%.
According to data from the CDC, an estimated 60,000 to 160,000 older adults in the U.S. Are hospitalized each year due to RSV infections, and 6,000 to 10,000 deaths are associated with the highly contagious virus in this group.
Throughout the meeting, the ACIP members expressed concerns over the trial data on the RSV vaccines and whether the participants enrolled represented those most at risk for serious outcomes.
"The populations that are at highest risk for severe disease were not included in the trials, and I think that the COVID-19 experience showed us that it is possible to do clinical trials that include people who have comorbidities," said Beth Bell, MD, MPH, of the University of Washington in Seattle.
Approvals of the two vaccines were based on efficacy data spanning a single RSV season. During the meeting on Wednesday, manufacturers presented data showing that vaccine efficacy largely held up through the first part of the second RSV season, but did drop slightly.
Data on GSK's adjuvanted RSV prefusion F protein-based vaccine (Arexvy) showed efficacy against lower-respiratory tract disease (LRTD) dropping from 83% in season one to 77% by the middle of season two, with protection against severe cases dropping from 94% to 85%, respectively.
For Pfizer's unadjuvanted bivalent RSV prefusion F protein vaccine (Abrysvo), protection against LRTD infections with three or more symptoms dropped from 89% in season one to 79% by the middle of season two, with protection against LRTD infections with two or more symptoms dipping from 65% to 49%.
Potential costs of the vaccine was another issue for ACIP, with developers Pfizer and GSK floating prices ranging from $180 to $295 for the new vaccines.
CDC's cost-effectiveness model based on one of the vaccines across two RSV seasons showed that for every 1 million vaccines given, 23,000 outpatient visits, 2,300 hospitalizations, and 120 deaths would be prevented among people 65 and over. For those ages 60 to 64 years, 18,000, 890, and 35, respectively, would be prevented per 1 million doses.
Other concerns stemmed from hints of lower efficacy when the RSV vaccines were given concurrently with the flu shot, with some members suggesting the shots could not be given at the same time.
The CDC noted that despite a signal for increased risk of Guillain-Barre Syndrome or other neurologic inflammatory events in the trials, the risks of these adverse events were not known, and that the agency would rely on ongoing post-marketing surveillance by manufacturers to continue monitoring these safety concerns.
Recommendations of the ACIP are not considered final until they are published in the Morbidity and Mortality Weekly Report.
Ingrid Hein is a staff writer for MedPage Today covering infectious disease. She has been a medical reporter for more than a decade. Follow
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Three Shots This Fall? What To Know About Getting The RSV, Flu And COVID Vaccines
The RSV season generally starts in the fall and peaks in the winter, but last year's struck a bit early. "So, my recommendation would be to get the RSV vaccine as soon as it's locally available," Presti says.
Pfizer, the manufacturer of one of the RSV vaccines, expects its shot will be available in the late summer or early fall; GlaxoSmithKline, the manufacturer of the other, is working on a similar timeline. (And there's little difference between the two approved shots, Presti adds, so again, it comes down to what's on hand.)
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For one, Schaffner says, "I don't think there are too many people who want to get three [shots] at the same time."
And in studies, the influenza antibody response was better when the flu and RSV vaccines were given separately, Schaffner explains, though more information on RSV vaccine co-administration is expected soon. That said, the COVID-19 boosters and flu shots can be given together — and last year, often were — so there's no need to make separate trips for the clinic or pharmacy for those.
How often will you need the three vaccines?The influenza vaccine is one you need every year, ideally by the end of October, the Centers for Disease Control and Prevention (CDC) says. And remember: Adults 65 and older should get the high-dose version for stronger protection. (The CDC estimates that 70 to 85 percent of flu-related deaths occur among adults 65 and older.)
The COVID-19 vaccine schedule is still in flux, though many experts are in favor of moving to an annual shot in the fall as the virus settles into a more seasonal pattern. For now, older adults should pay attention to recommendations from health officials and stay up to date on their boosters. The CDC recently gave the OK for adults 65 and older to go back for a second dose of the bivalent booster.
As for RSV, Schaffner says the duration of protection from the vaccine has yet to be determined. "Early data indicate that the protection may extend beyond one year," he said, meaning an annual shot might not be necessary. "That said, stay tuned for further developments."
If getting three shots this fall seems like a lot, consider the alternative, Presti says. A vaccine is "a whole lot less of a stress on your immune system" than getting infected and seriously ill from one, or all, of these common viruses. "I understand that people are tired of it, but it's sort of something we should think about getting used to as just a way of preventing disease and keeping ourselves healthy."
Flu Vaccine Does Protect Older People
Mar. 23 --
WEDNESDAY, Oct. 3 (HealthDay News) -- If you're over 65, getting an annual flu shot will reduce the risk you'll be hospitalized with flu complications by 27 percent and cut your risk of flu-related death by 48 percent.
That's the conclusion of new research published in the Oct. 4 issue of the New England Journal of Medicine.
"This is a bad disease but a good vaccine," said the study's lead author, Dr. Kristin Nichol, chief of medicine at the VA Medical Center in Minneapolis. "Many people fail to appreciate the serious complications of influenza."
Not everyone is convinced, however, that the flu vaccine is quite so effective in the elderly. A study released last week in the October issue of The Lancet Infectious Diseases questioned death-rate reductions seen in many previous studies. The researchers behind last week's study pointed out that many studies fail to include those over 70 -- and thus, most at risk of flu complications -- and that the people who receive flu vaccines may actually be healthier than those who don't.
But, Nichol's study was designed to answer some of those concerns. And even after compensating for numerous factors, the researchers still found that the flu vaccine reduces hospitalizations and death rates in the elderly.
"I think this study is reassuring, and it does the best job you can do to assess the efficacy of flu vaccine in the elderly," said Dr. John Treanor, author of an accompanying editorial in the New England Journal of Medicine, and a professor of medicine at the University of Rochester Medical Center, in New York.
"The vaccine is nowhere near 100 percent effective, and it's probably true that the elderly don't respond as well as younger people do. But, that does not mean that we shouldn't use the vaccine in older people, but that we should think about other ways to prevent the disease," said Treanor, adding that he'd like to see many more health-care workers receive the vaccination, as well as more healthy children.
Each year, as many as 20 percent of the U.S. Population is infected with the flu, according to the federal Centers for Disease Control and Prevention. As many as 200,000 people are hospitalized annually due to flu complications, and 36,000 people die each year because of the flu. Those most at risk of serious flu complications include the elderly and young children, the CDC says.
The new study began in 1990 and included data through the 1999-2000 flu season for people from 18 different groups of community-dwelling elderly members of one health maintenance organization. Additionally, information on members of two other HMOs was included from 1996 through 2000.
The study included almost 300,000 unvaccinated people and more than 415,000 vaccinated individuals. All were over 65 years old.
In the entire study group, there were 4,599 hospitalizations and almost 9,000 deaths from influenza during the 10-year study period. On average, hospitalization rates were 0.7 percent for unvaccinated people and 0.6 percent for those vaccinated. On average, death rates were 1.6 percent and 1.0 percent, respectively.
The researchers found that those rates varied from flu season to flu season, with more hospitalizations and deaths occurring in years when the flu vaccine wasn't a good match against the strains of circulating flu.
The researchers also looked to see if hospitalizations and death rates were lower in the summer, which would suggest that the effect wasn't from the vaccine. They didn't find such an association, suggesting that the reduction during influenza season was, in fact, due to the vaccine.
"This is the most definitive look linking outcomes to vaccination status," Treanor said.
Nichol said: "I think this study goes a long way to addressing concerns and shows what the influences of the influenza vaccine might be even after taking into account age, health conditions and previous hospitalizations."
She added that, in addition to preventing hospitalizations and deaths, the flu vaccine is "highly cost-effective and even cost-saving."
More information
To learn more about flu vaccine, visit the U.S. Centers for Disease Control and Prevention.
SOURCES: Kristin Nichol, M.D., M.P.H., M.B.A., chief of medicine, VA Medical Center, and professor of medicine, University of Minnesota, Minneapolis; John Treanor, M.D., professor of medicine, University of Rochester Medical Center, Rochester, N.Y.; Oct. 4, 2007, New England Journal of Medicine
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